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CTRI Number  CTRI/2023/05/052831 [Registered on: 18/05/2023] Trial Registered Prospectively
Last Modified On: 27/02/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   A clinical trial to study effects of Denosumab in the Treatment of Postmenopausal Osteoporosis. 
Scientific Title of Study   A phase IV, open label, single-arm, multi-centre clinical study to evaluate the safety and efficacy of denosumab in patients with postmenopausal osteoporosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ALK23/DEN3 Version 2.1, 10/Mar/2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akhilesh Sharma 
Designation  President & Chief Medical Officer 
Affiliation  Alkem Laboratories Limited 
Address  Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai, MAHARASHTRA 400013, India

Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  022-39829999  
Fax    
Email  akhilesh.sharma@alkem.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Akhilesh Sharma 
Designation  President & Chief Medical Officer 
Affiliation  Alkem Laboratories Limited 
Address  Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai, MAHARASHTRA 400013, India


MAHARASHTRA
400013
India 
Phone  022-39829999  
Fax    
Email  akhilesh.sharma@alkem.com  
 
Details of Contact Person
Public Query  
Name  Dr Dattatray Pawar 
Designation  Senior Manager 
Affiliation  Alkem Laboratories Limited 
Address  Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai MAHARASHTRA 400013, India

Mumbai (Suburban)
MAHARASHTRA
400013
India 
Phone  022-39829999  
Fax    
Email  dattatray.pawar@alkem.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg, Lower Parel, Mumbai –400013, Maharashtra 
Enzene Biosciences Limited, Plot No. 165/1/26, Block T, Bhosari MIDC Area, Pune-411057,Maharashtra 
 
Primary Sponsor  
Name  Enzene Biosciences Limited 
Address  Enzene Biosciences Limited, Plot Number 165/1/26, Priyadarshani Society, Next to Gujjar Bharath gas) T 26, Internal Rd, MIDC, Bhosari, Pune, Maharashtra 411026 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Alkem Laboratories Limited  ALKEM HOUSE, “Devashish”, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel west, Mumbai 400013 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karthik Subramanian  Hira Mongi Navneet Hospital  Shree Pragati Foundations, Hira Mongi Navneet Hospital, Valji Ladha Road, Near Kalidas Natya Gruh, Mulund West, Mumbai, Maharashtra- 400080, India
Mumbai
MAHARASHTRA 		 9082780282

drkarthik.hmn@gmail.com 
Dr Pravin Markade   Ishwar Institute of Health Care   Ishwar Heights , 1st Floor , Plot no 7 , Gut no 6/1, beside Punjabi Bhavan , Padegaon , Aurangabad - 431002, Maharashtra , India
Aurangabad
MAHARASHTRA 		 9822314268

drpravinmarkade.iicr@gmail.com 
Dr Hrishikesh Patkar  Lifepoint Hospital   145/1 , Mumbai Bangalore Highway , Near Hotel Sayaji , Wakad , Pune -411057 Maharashtra , India
Pune
MAHARASHTRA 		 9011267776

patkarhrishikesh9@gmail.com 
Dr Onkar Gavali   Lokmanya Hospital  Dhatrak Phata , Mumbai-Agra Highway , Near Bali Mandir , Panchavati, Nashik -422003
Nashik
MAHARASHTRA 		 9860972279

omkarina_13@yahoo.co.in 
Dr Swaroop Solunke  Medipoint Hospital  241/1 New D.P Road , Aundh , Pune-411007, Maharashtra , India
Pune
MAHARASHTRA 		 9921101070

drswaroopsolunke.medipoint@gmail.com 
Dr Amit Supe   St. Georges Hospital   St. George Hospital , PD mello road , fort road, CSMT, Mumbai -400001
Mumbai
MAHARASHTRA 		 8793086166

amitsupe1@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee of Ishwar Institute of Health Care, Aurangabad  Approved 
Institutional Ethics Committee , GGMC, Mumbai  Submittted/Under Review 
Institutional Ethics Committee Hira Mongi Navneet Hospital  Approved 
LPR Ethics Committee, Pune   Approved 
Pentamed Ethics Committee, Pune  Approved 
Shree Siddhivinayak Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Denosumab 60 mg Injection  Denosumab (Enzene Biosciences Ltd) 60 mg subcutaneously once only 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Women with at least 5 years post menopause, aged > 50 to 80 years.
2. Have low bone mass density test (dual energy X-ray absorptiometry) Bone mineral Density Tscore < -2.5 standard deviation at any one of two sites measured ( Lumbar spine [L1-L4] and Femoral neck)
3. Women giving written, voluntary informed consent for study participation.  
 
ExclusionCriteria 
Details  1. Known hypersensitivity to denosumab or any of its excipients
2. Pre-existing hypocalcemia
3. Subject previously treated with Denosumab
4. Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D test, vitamin D < 20 ng/mL at screening
5. Subjects with hyperparathyroidism or hypoparathyroidism at screening
6. Subjects with thyroid dysfunction
7. Metabolic bone diseases other than postmenopausal osteoporosis including hyperthyroidism, Cushing diseases and Pagets diseases.
8. Any of the following oral/dental conditions:
a. prior history or current evidence of osteomyelitis or osteonecrosis of jaw
b. Active dental or jaw condition which requires oral surgery
c. Planned invasive dental procedure
d. Non-healed dental or oral surgery
9. Any significant medical condition in the opinion of the investigator that does not allow the participation of the patient in the study
10. Subjects who are unwilling or unable to comply with the requirements of the protocol 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Number of AEs (adverse events) and Number of adverse reactions (ARs)  Baseline, week 12, week 24 and week 26 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of serious adverse events (SAEs) and serious adverse drug reactions (SADRs) during the study period.
2. Percentage change from baseline to Week 24 in bone mineral density (BMD) at lumbar spine and femoral neck. 		 24 week 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   13/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   A phase IV, open label, single-arm, multi-centre clinical study to evaluate the safety and efficacy of denosumab in patients with postmenopausal osteoporosis.

A total 200 subject who meet eligibility criteria will be given Denosumab (Enzene Biosciences Ltd) 60 mg subcutaneously once only.

The study duration will be approximately 53 weeks considering 24 weeks of recruitment period and 29 weeks of study period.

The study comprises of 3 periods:

Screening Period: It will last up to 3 weeks
Treatment Period: It will last for 24 weeks; all subjects will receive Denosumab (Enzene Biosciences Ltd) 60 mg subcutaneously once only;
Follow-up Period: It will last for 2 weeks after completion of Treatment Period.

Primary Objectives:
The primary objective of this study is to evaluate safety of denosumab in patients with postmenopausal osteoporosis.

Secondary Objectives:
To evaluate efficacy of denosumab in patients with postmenopausal osteoporosis
 
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